MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Catalog Number 400.834

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: only the event month and year are known.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, that internal synthes found 113 broken screws in (b)(6).There were no adverse consequences to a patient.This (b)(4) which captures the 3 of 113 devices.This report involves one (1) ti low profile neuro screw self-drilling 4mm.This is report 8 of 10 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6- the cranial-scr plusdrive ø1.6 self-drill l4 (p/n: 400.834, lot #: h855734) was returned and received.Upon visual inspection, the cross-slot feature was found to be visibly damaged amongst returned screws.The cross-slot feature may impact functionality with the mating screwdriver but does not directly affect material strength.Due to the severe cross slot damage, it appears there was an issue with the insertion of the screws.The thread tips are worn/damaged.No other signs of damage were observed with the returned device.The broken complaint condition was not confirmed during the investigation.The complaint condition of deformation was confirmed for the cranial-scr plusdrive ø1.6 self-drill l4 (p/n: 400.834, lot #: h855734).During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The investigation found no evidence of a manufacturing defect or raw material issue.A root cause could not be determined during an investigation; however, it is possible the damage could be attributed to unintended forces applied to the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot manufacturing location: monument.Manufacturing date: 19-mar-2019.Part number: 400.834, ti low profile neuro screw self-drilling 4mm.Lot number: h855734 (non-sterile).Component part(s) reviewed: part number:21015, tialnbr 14.00.Lot number: h692284.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d10 e1 e3 h4 device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10167860
• MDR Text Key: 195586344
• Report Number: 8030965-2020-04259
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819753457
• UDI-Public: (01)07611819753457
• Combination Product (y/n): N
• PMA/PMN Number: K022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834
• Device Lot Number: H855734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 06/23/2020; 08/03/2020
• Supplement Dates FDA Received: 07/14/2020; 08/04/2020
• Patient Sequence Number: 1